Totest Sensory Symptoms in Active VitiligoNCT05390164
Sensory Symptoms in Active Vitiligo
An observational study of Totest Sensory Symptoms in Active Vitiligo, run by Cairo University.
Trial summary
This work aims to assess sensory symptoms in early active vitiligo patients (segmental, non-segmental, or mixed) and to measure 3 neuropeptides expression in their lesional skin [neuropeptide Y(NPY), calcitonin gene-related peptide (CGRP), and nerve growth factors (NGF)] to correlate neuropeptide levels, sensory… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Totest Sensory Symptoms in Active Vitiligo
- What is being tested?
- skin biopsy
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2022to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Active vitiligo patients
Who may be able to join
- Active and stable vitiligo
Who cannot join
- Diabetic or other associated disease
About this study
Official title: Sensory Symptoms as an Early Manifestation of Active Vitiligo: a Case-control Clinical and Molecular Study
This work aims to assess sensory symptoms in early active vitiligo patients (segmental, non-segmental, or mixed) and to measure 3 neuropeptides expression in their lesional skin [neuropeptide Y(NPY), calcitonin gene-related peptide (CGRP), and nerve growth factors (NGF)] to correlate neuropeptide levels, sensory symptoms, and functions, with criteria of disease activity and perceived stress scale.
Read the detailed description
Study Design: Case-control study Population: 45 patients with active vitiligo and 45 patients with stable vitiligo
Inclusion criteria:
Age: 18 years old and older Sex: both sexes
Exclusion criteria:
Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post-inflammatory hyperpigmentation, and leprosy as excluded by lack of accentuation by wood's light examination. - Cases who received treatment (systemic or topical) in the last 3 months before sampling. - Neurological or other diseases that cause itching. - Medical history of DM, HTN, or other systemic diseases, history of associated autoimmune diseases.
Assessment will be carried as follows: • History of itching or other abnormal neurological sensations as paresthesia and numbness. Aggravating factors (e.g. dryness, hot environment, sun exposure, ..etc), alleviating factors of itching Type of vitiligo (segmental, unilateral, vulgaris). • Assessment of activity by assessing: koebner's phenomenon, confetti depigmentation, trihypochrome areas, poorly defined borders, inflammatory signs (e.g eye inflammation and hearing loss), and leukotrichia. • Assessment of sensory symptoms and signs (fine touch, crude touch, pain, and sweating by starch iodine test) in active vitiliginous patches. • Clinical assessment: the vitiligo area score index (VASI), vitiligo extent scores (VES), vitiligo disease activity score (VIDA) (Feily, 2014) will be assessed in every participant and demographic data
- Being tested
- skin biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyDiagnostic test
skin biopsy to be analyzed by ELISA
| Study group | Role | What they receive |
|---|---|---|
| Active vitiligo | Not described Receives: Diagnostic Test: skin biopsy | |
| Stable vitiligo | Not described Receives: Diagnostic Test: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropeptide
laboratory test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start25 May 2022 (estimated)
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Totest Sensory Symptoms in Active VitiligoStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar El Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390164
- Sponsor's protocol ID
- Pruritis in vitiligo
- Status last verified
- May 2022
- First submitted
- 20 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Sayed H, El Wakeel H, Nour Z, Mohyeeldeen R, Hafez V. Sensory Symptoms as an Early Manifestation of Active Vitiligo: A Case-Control Clinical and Molecular Study. Pigment Cell Melanoma Res. 2025 Jan;38(1):e13223. doi: 10.1111/pcmr.13223.
PubMed 39869070
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Symptoms as an Early Manifestation of Active Vitiligo: a Case-control Clinical and Molecular Study
- ClinicalTrials.gov ID
- NCT05390164
- Acronym / sponsor ID
- Pruritis in vitiligo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (estimated)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Aug 2022 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work aims to assess sensory symptoms in early active vitiligo patients (segmental, non-segmental, or mixed) and to measure 3 neuropeptides expression in their lesional skin [neuropeptide Y(NPY), calcitonin gene-related peptide (CGRP), and nerve growth factors (NGF)] to correlate neuropeptide levels, sensory symptoms, and functions, with criteria of disease activity and perceived stress scale.
Detailed description
Study Design: Case-control study Population: 45 patients with active vitiligo and 45 patients with stable vitiligo
Inclusion criteria:
Age: 18 years old and older Sex: both sexes
Exclusion criteria:
Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post-inflammatory hyperpigmentation, and leprosy as excluded by lack of accentuation by wood's light examination. - Cases who received treatment (systemic or topical) in the last 3 months before sampling. - Neurological or other diseases that cause itching. - Medical history of DM, HTN, or other systemic diseases, history of associated autoimmune diseases.
Assessment will be carried as follows: • History of itching or other abnormal neurological sensations as paresthesia and numbness. Aggravating factors (e.g. dryness, hot environment, sun exposure, ..etc), alleviating factors of itching Type of vitiligo (segmental, unilateral, vulgaris). • Assessment of activity by assessing: koebner's phenomenon, confetti depigmentation, trihypochrome areas, poorly defined borders, inflammatory signs (e.g eye inflammation and hearing loss), and leukotrichia. • Assessment of sensory symptoms and signs (fine touch, crude touch, pain, and sweating by starch iodine test) in active vitiliginous patches. • Clinical assessment: the vitiligo area score index (VASI), vitiligo extent scores (VES), vitiligo disease activity score (VIDA) (Feily, 2014) will be assessed in every participant and demographic data
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active vitiligo | – | Diagnostic Test: skin biopsy |
| Stable vitiligo | – | Diagnostic Test: skin biopsy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Active vitiligo patients
Key inclusion criteria (1 listed)
- Active and stable vitiligo
Key exclusion criteria (1 listed)
- Diabetic or other associated disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsyskin biopsy to be analyzed by ELISA | Diagnostic test | Active vitiligo, Stable vitiligo |
Primary outcome
Neuropeptide
Time frame: 3 months
laboratory test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 39869070El Sayed H, El Wakeel H, Nour Z, Mohyeeldeen R, Hafez V. Sensory Symptoms as an Early Manifestation of Active Vitiligo: A Case-Control Clinical and Molecular Study. Pigment Cell Melanoma Res. 2025 Jan;38(1):e13223. doi: 10.1111/pcmr.13223.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Totest Sensory Symptoms in Active Vitiligo, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropeptide (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05390164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.